Kornimate/medical-research-clean huggingface dataset:
light, metabolic syndrome and alzheimer's disease - aim 2

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Type2 Diabetes

Summary: to test the long term effect of a light treatment on cognition, sleep and metabolism in patients with mild cognitive impairment (mci) or mild alzheimer's disease or related dementia (adrd).

test if a tailored light intervention (tli) that promotes entrainment can improve sleep disturbances, inflammation, insulin sensitivity (si) and glucose disposal (sg) and cognition in patients with mci and mild adrd and sleep disturbances. using a single-arm, between-subjects, placebo-controlled study the investigators will investigate if long-term (6-month) exposure to tli improves glucose homeostasis and insulin sensitivity in patients with mci and mild ad who suffer from sleep disturbance and are living at home. participants will be recruited from the mount sinai ad research center (adrc) and randomized to receive the tli (or comparison control treatment) at home. the investigators hypothesize that, compared to the comparison light, a tli will increase entrainment, improve sleep, reduce depression, reduce inflammation, improve metabolic control, increase insulin sensitivity, and reduce susceptibility to t2dm and metabolic disease during and after the completion of the 6-month intervention.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment * mild alzheimer's disease * sleep disturbance * live at home exclusion criteria: * blindness * insulin-dependent diabetes patients * macular degeneration * severe sleep apnea
a study to evaluate the efficacy and safety of liso-cel compared to standard of care in adults with relapsed or refractory follicular lymphoma

Conditions: Relapsed or Refractory Follicular Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of liso-cel compared to standard of care in adults with relapsed or refractory follicular lymphoma.

the purpose of this phase iii study is to evaluate the clinical benefit of liso-cel for the treatment of r/r fl by comparing it to standard of care therapy in patients with r/r fl, with progression-free survival (pfs) as the primary endpoint. the primary objective is to demonstrate superiority of the liso-cel treatment strategy over standard of care (soc) therapy with respect to progression-free survival (pfs) determined by independent review committee (irc) based on the lugano response criteria. participants randomized to arm a (standard of care) will receive rchop, br, or r2 based on investigator choice and this has to be determined prior to randomization. participants randomized to arm b (liso-cel treatment) will receive a single infusion car-positive viable t-cells.

Eligibility criteria:
inclusion criteria * participants must have measurable disease. * participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment. * participants must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * participants that have histologically confirmed follicular lymphoma (fl) (grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening. * participants that have relapsed or refractory fl, as assessed by the investigator. * participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-cd20 antibody and an alkylating agent. * participants that received one prior line of systemic therapy are eligible if they present with high risk features. exclusion criteria * participants must not have any history of heart problems. * participants must not have any bleeding disorders. * participants must not have any central nervous system involvement by follicular lymphoma or other brain conditions. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: lisocabtagene maraleucel liso-cel follicular lymphoma
feasibility study of radiation therapy with wide detector 4dct scanning for primary or metastatic lung cancer

Conditions: the Diffenence of Different Detector Row 4DCT，Especially in Artifects，Radiation Dose and Target Volume

Summary: currently there are very few studies using wide-body detectors for 4dct to determine lung tumor volume and comparing them with conventional detector 4dct images, and no prospective clinical trials comparing 4dct images from different width detectors have been queried, therefore, in this study, we will prospectively explore in a body model and patients: 1) the degree of artifacts, tumor volume, and radiation dose of the 4dct scans performed by different width detectors. differences, and scanning radiation dose. (ii) whether there are differences in different tumor itv outlining modalities on 4dct with different detector widths.


Eligibility criteria:
inclusion criteria: * 1. voluntarily participate in and sign the informed consent in person. 2. over 18 years old, gender unlimited; 3. after imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, mdt decided to treat sbrt 4. clinical stage ia-iv (ct1-4n1-3m0-1); 5. no serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency; 6. coagulation function: activated partial thromboplastin time (aptt) \ 3 months; exclusion criteria: * 1. patients could not tolerate or were unwilling to undergo ct examination; 2. the primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy; 3. subjects who have received other drug trials within the last 1 month; 4. people with severe allergic history or idiosyncrasies; 5. patients with a history of severe lung or heart disease; 6. severe comorbidities, such as uncontrolled hypertension, heart failure, etc.; 7. pregnant or lactating women; 8. previous history of malignant tumor; 9. refusal or inability to sign informed consent to participate in the trial; 10. currently or planning to participate in other clinical trials;
comparison of erector spinae plane block with thoracic paravertebral block for video assisted thoracoscopic surgery

Conditions: Postoperative Pain

Summary: erector spinae plane block (espb) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. it was first described by forero et al. in 2016, effectiveness being reported in four cases. the paravertebral block has been successfully used in various surgical patient groups for purposes of anesthesia or postoperative pain management such as thoracotomy, breast surgery and abdominal surgery. the aim of this study is to compare the analgesic effects of erector spinae plane block and paravertebral block in patients undergoing video assisted thoracoscopic surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients * undergoing video assisted thoracoscopic surgery exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases
assessment of efficacy & tolerance of urgo 310 3166 dressing in local venous or mixed leg ulcers

Conditions: Ulcers, Leg

Summary: assessment of efficacy \& tolerance of urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

assessment of efficacy, tolerance and acceptability of urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in france.

Eligibility criteria:
inclusion criteria: 1. male or female over 18 years old who has provided his/her written informed consent 2. patient who can be monitored by the same investigation team throughout the whole duration of the study 3. patient who agrees to wear an effective venous compression system every day, associated with the trial dressing 4. leg ulcer with an ankle brachial pressure index (abpi) not less than 0.7 and not more than 1.3 5. ulcer area between 3 and 20 cm2 6. ulcer duration between 3 and 18 months, 7. ulcer presenting a surface wound bed covered with 50% or more by granulation tissue 8. moderately or heavily exudative ulcers. exclusion criteria: a. clinical infection on the wound bed.
escalating and cumulative-dose study of pharmacokinetics (pk), pharmacodynamics (pd) and safety of a006

Conditions: Asthma; Bronchospasm; Chronic Obstructive Pulmonary Disease (COPD)

Summary: the main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of a006 (albuterol dry powder inhaler (dpi)), in comparison with those of an active control, proventil-hfa (albuterol metered dose inhaler (mdi)), and a placebo dpi in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.


Eligibility criteria:
inclusion criteria: * body weight ≥ 50 kg for men and ≥ 45 kg for women, and bmi within the range of 18.5 - 30.0 kg/m2 inclusive; * sitting blood pressure ≤ 135/90 mmhg; * demonstrating negative alcohol/drug screen tests; * demonstrating negative hiv, hbsag and hcv-ab screen tests; * with mild-to-moderate persistent asthma for at least 6 months prior to screening, and having used inhaled β-agonist(s) for asthma control; * demonstrating a mean screening baseline fev1 at 50.0 - 85.0 % of predicted normal; * demonstrating a ≥ 15.0% airway reversibility in fev1 within 30(±5) min after inhaling 2 actuations of proventil-hfa; * demonstrating peak inspiratory flow rate within 80-150 l/min; * demonstrating proficiency in the use of dpi and mdi after training; * females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; * having properly consented to participate in the trial. exclusion criteria: * smoking history of ≥ 10 pack-years, or having smoked within 6 months prior to screening; * upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk; * asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior; * any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs, besides asthma; * concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignancies, or other illnesses that could impact on the conduct, safety and evaluation of the study; * known intolerance or hypersensitivity to any of the ingredients of the a006 or proventil-hfa; * use of prohibited drugs or failure to observe the drug washout restrictions; * having been on other clinical drug/device studies in the last 30 days; * having donated blood within the last 30 days prior to screening.

Keywords: asthma bronchospasm copd reversibility efficacy
eldertree smart system for older adults

Conditions: Chronic Pain

Summary: multiple chronic conditions (mccs) are costly and pervasive among older adults. mccs account for 90% of medicare spending, and 65% of medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. mccs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. the primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (elder tree, or et) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. et is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. an agency for health care research and quality (ahrq)-funded randomized controlled trial (rct) found that et improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. however, many people did not use it extensively, which is a common problem with all web apps.


Eligibility criteria:
inclusion criteria: * be ≥60 years old; * have been treated in university of wisconsin (uw) health clinics, with no plans to leave during the study period (only relevant for uw health patients, not patients recruited from the community); * have a chronic pain diagnosis and a medical diagnoses of three or more of the following common chronic conditions: chronic obstructive pulmonary disease (copd), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, bmi 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function; * be willing to share healthcare use (e.g. 30-day readmissions) in electronic health records (only relevant for uw health patients, not patients recruited from the community); and * allow researchers to share information about a patient's health status with their primary care physician (pcp). exclusion criteria: * require an interpreter * have a medical diagnosis of any of the following: * alzheimer's * schizophrenia/other psychotic disorders * dementia * autism spectrum disorder * known terminal illness with less than 6 months to live * acute medical problem requiring immediate hospitalization

Keywords: chronic conditions voice-activated "smart" technology
xience prime japan post-marketing surveillance (pms)

Conditions: Angina; Coronary Occlusion; Coronary Artery Disease; Coronary Artery Stenosis; Myocardial Ischemia

Summary: the objectives of the pms are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (xience prime) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

the primary objectives of the pms are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (xience prime) as well as to collect information on evaluation of the efficacy and safety for reevaluation by pharmaceuticals and medical devices agency (pmda).

Eligibility criteria:
inclusion criteria: * patients with ischemic heart disease who are eligible for treatment with xience prime everolimus eluting stent * patient provides informed consent form exclusion criteria: * if it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the pms.

Keywords: angioplasty drug eluting stents stents real world
lifetech cera™ pfo occluder post-market clinical follow-up

Conditions: Patent Foramen Ovale; PFO

Summary: the objective of this post-market registry is to assess the clinical use of the lifetech cera™ pfo occluder in a real-world and on-label fashion.


Eligibility criteria:
inclusion criteria: 1. patients with a confirmed diagnosis of patent foramen ovale (pfo); 2. associated with tia or cryptogenic stroke; 3. patients was implanted with the investigational device as per ifu instructions; 4. patients or legally authorized representatives have signed data release consent or equivalent documents. exclusion criteria: 1. any contraindication mentioned in the corresponding ifu; 2. patients did not conduct any follow up visit after hospital discharge.

Keywords: lifetech cera pfo occluder
the effect of local anesthesia on control of intraoperative physiologic parameters and post operative comfort

Conditions: Pain, Procedural

Summary: the purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (ga) and when it is not used.

local anesthesia is a widely used tool to ensure patient safety and comfort in the dental office. this is usually accomplished by administering a shot of numbing medicine (local anesthesia) in different parts of the mouth. local anesthesia is an important tool used for care in the dental office however despite its standardized use in dental clinics use of local anesthetic is not standardized for use in dental cases under ga. in the literature there is some evidence suggesting that it has some marginal benefit for pain control short term post operatively and control of vital signs during surgery. some evidence also suggests that due to its use there can be increase in post-operative lip chewing and cheek biting due to the numb sensation. additionally, it has been seen that due to the numb sensation that children can be more irritable during when waking up after surgery. the study section will have 60 participants of which one half will receive local anesthesia for restorative dental care under ga and the other half will receive conventional no anesthesia for restorative dental treatment under ga, based on random assignment (like the flip of a coin). there is an equal chance of being assigned to either group prior to the consented treatment. before the surgery, a nurse will access the child's overall pain and comfort. the study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart rate, and breathing duration throughout the procedure. after the child has completed the surgery a nurse will again access the child's overall pain and comfort. lastly, parents will be contacted that evening of surgery by a member of the study team to check up on the child and will be asked some questions to access the child's comfort at home.

Eligibility criteria:
inclusion criteria: • pediatric patients undergoing ga for dental restorative work at virginia commonwealth university children's hospital of richmond pavilion and brook road centers exclusion criteria: * children with any sensory or behavioral issues * patients requiring extractions or surgical procedures
safety and efficacy of ypeg-rhg-csf in cancer patients receiving chemotherapy

Conditions: Non Small Cell Lung Cancer; Breast Cancer

Summary: this study is to examine which dose of ypeg-rhg-csf, once-per-cycle, has similar efficacy and safety, comparing to peg-rhg-csf, once-per-cycle, in chemotherapy-induced neutropenia


Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer or breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy * karnofsky score ≥ 70 * life expectancy \> 3 months * age: 18～70yrs. * peripheral blood test: wbc≥3.5×106/mm3, plt≥100×106/mm3, anc≥1.5×106/mm3; normal bone marrow function; bone marrow biopsy shows active hematopoietic without cancer cells. * normal coagulation function, no evidences of hemorrhage tendency. * no exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion. * adequate liver, cardiac, kidney function. indicators of liver function test ≤ 2.5uln, indicators of kidney function test ≤ 1uln * understand and voluntarily sign an informed consent form. exclusion criteria: * pregnant or lactating females * evidence of tumor metastasis in bone marrow * lack insight due to tumor metastasis in the central nervous system * prior bone marrow transplant or stem cell transplant * infective symptom before enrollment into this study * other malignancy history * known hypersensitivity to any component of the drug(e.g. rh-g-csf) that to be administered * subject enrolled in any other investigational drug or device trial within 3 months of informed consent date * drug abuser or alcoholist * prior radiotherapy or expected to received radiotherapy * unstable or uncontrolled cardiac or hypertension * other conditions which in the opinion of the investigator preclude enrollment into the study

Keywords: neutropenia febrile neutropenia peg-rhg-csf myelosuppressive chemotherapy
a comparison of symbicort® single inhaler therapy and conventional best practice for the treatment of persistent asthma

Conditions: Asthma

Summary: the primary objective is to compare the efficacy of symbicort single inhaler therapy with treatment according to conventional best practice in adult patients with persistent asthma.

a secondary objective is to collect safety data for treatment wtih symbicort single inhaler therapy in adult patients with persistent asthma.

Eligibility criteria:
inclusion criteria: * signed informed consent form. if the patient cannot read and write, verbal consent from the patient is required. * ability to read and write in turkish * female or male outpatients aged 18 years * minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition * prescribed inhaled glucocorticosteroid (gcs) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to visit 1 * either: daily maintenance treatment with both inhaled gcs and long-acting b2-agonist (laba) or daily treatment with inhaled gcs alone (i.e. without laba); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 peak expiratory flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment exclusion criteria: * previous treatment with symbicort single inhaler therapy * use of any b-blocking agent, including eye drops * use of oral gcs as maintenance treatment * known or suspected hypersensitivity to study therapy or excipients * a history of smoking 10 pack years * pregnancy, breast-feeding or planned pregnancy during the study. fertile women not using acceptable contraceptive measures, as judged by the investigator * any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study

Keywords: symbicort turbuhaler persistent asthma
indomethacin use in pain relief during intrauterine device insertion

Conditions: Family Planning

Summary: the aim of the investigators study is to test the analgesic effect of rectal indomethacin during intrauterine device insertion.


Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to intrauterine device insertion * women who will accept to participate in the study exclusion criteria: * any contraindication to intrauterine device placement
an information-motivation-behavioral skills (imb) intervention to promote human papillomavirus vaccination among women

Conditions: Human Papillomavirus Infection

Summary: hpv infections are prominent among college-aged women. although hpv vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. this study explored the utility of an information-motivation-behavioral skills intervention in promoting hpv vaccination knowledge, motivation, and behavioral skills among college aged women.

hpv infections are prominent among college-aged women. although hpv vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. this study explored the utility of an information-motivation-behavioral skills intervention in promoting hpv vaccination knowledge, motivation, and behavioral skills among college aged women. methods: participants were randomly assigned to a single-session intervention or attention-control arm and were assessed at pre-intervention, post-intervention, and at 1-month follow-up.

Eligibility criteria:
inclusion criteria: * enrollment in a psychology course at the university of connecticut exclusion criteria: * completion of the hpv vaccination series

Keywords: hpv